Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period

Completed

• Conditions: Gastroesophageal Reflux; Pharyngeal Diseases
• Interventions: Drug: Rabeprazole Sodium

• Registration Number: NCT00614536
• Lead Sponsor: Janssen Korea, Ltd., Korea

Brief Summary

The purpose of this observational study is to examine RSI (Reflux Symptom Index) and RFS (Reflux Finding Score) by treatment period before and after rabeprazole treatment in LaryngoPharyngeal Reflux Disease(LPRD) patients.

Detailed Description

This clinical study is a multicenter, open-label, prospective, observational study of outpatients who visit the department of otolaryngology (branch of medicine that deals with diagnosis and treatment of diseases of the ear, nose, and throat) under routine practice. This study will examine RSI (Reflux Symptom Index) and RFS (Reflux Finding Score) by treatment period (before and after rabeprazole treatment) in patients with LaryngoPharyngeal Reflux Disease(LPRD). Among the patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux, those needing rabeprazole sodium treatment according to the doctor's discretion are eligible for enrollment. This study will explore the correlation between RSI and RFS and will examine major reflux symptoms and types of lesions, to find the most reliable factors in diagnosing LPRD and judging therapeutic effectiveness of treatments. LPRD is a disease with various symptoms and causes lesions by exposing the upper respiratory system to gastric acid and stomach contents. RSI and RFS can be used to diagnose LPRD in a relatively objective manner by scoring items of symptoms and lesions particular to LPRD. Evaluations will be performed four times from baseline to week 12. Observational Study - one tablet of rabeprazole 10 mg or 20 mg once daily for 12 weeks

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-01-24
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-13
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1142

Inclusion Criteria

• Patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux
• Patients who need rabeprazole treatment according to the doctor's discretion
• Patients who have signed an informed consent document indicating that they understand the purpose of and procedures required for the observational study and they agree to provide their information

Exclusion Criteria

• Patients who took rabeprazole within the past one month
• Patients who are hypersensitive to any of rabeprazole or benzimidazole
• Patients with severe hepatic impairment
• Pregnant or lactating women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	Rabeprazole Sodium	-

Primary Outcome Measures

Name	Time	Method
The change from baseline in RSI and RFS score during LPRD treatment period,	12 weeks

Secondary Outcome Measures

Name	Time	Method
LRPD treatment period with rabaprazole sodium	12 weeks
Regional difference in distribution of symptoms and lesions, and in severity	12 weeks